HIV InfectionsCHRONONCT04888754
A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands
An observational study of HIV Infections and HIV-1-infection, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
A prospective non-interventional cohort study at Erasmus MC of adult chronic HIV infected patients of ≥18 years of age who initiate antiretroviral therapy in routine care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, HIV-1-infection, HIV-2 Infection
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 May 2021to Jan 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are 18 years or older with a confirmed HIV infection without prior exposure to cART (treatment naïve). Prior use of pre-exposure prophylaxis is allowed.
Who may be able to join
- Age >18 years.
- Confirmed HIV-1 or HIV-2 infection
- Judged willing to initiate and adhere to cART by the HIV physician.
Who cannot join
- Inability to place venous catheters to draw blood.
- Major comorbidities:
- Severe symptomatic anemia or recent symptomatic cardiovascular event (un-stable angina pectoris, decompensated heart failure, myocardial infarction).
- The inability to participate due to any other relevant social, environmental,psychological, factors or according to the HIV treating physician's judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands: The CHRONO Project
A prospective non-interventional cohort study at Erasmus MC of adult chronic HIV infected patients of ≥18 years of age who initiate antiretroviral therapy in routine care.
Read the detailed description
HIV cannot be cured with the current treatment armamentarium. A reservoir of latently HIV infected long lived CD4+T-cells is present in patients with HIV that are not affected by antiretroviral therapy. The evolution of this reservoir after therapy initiation is ill understood, as are the potential strategies to eradicate this reservoir. This study aims to anticipate on future HIV cure strategies by building a cohort to study ex vivo the reservoirs of HIV patients, the obstacles to cure HIV, and new therapeutic compounds and strategies.
Main study parameters/endpoints:
- Change in viral reservoir size after antiretroviral treatment initiation.
- Evolution of phenotypical and functional aspects of the anti-HIV host immune responses.
- Ex vivo activity of established and novel HIV latency reversing agents.
- Variance in HIV reservoir and host immunity between HIV subtypes and clinical variables.
A project from the Erasmus MC HIV Eradication Group (EHEG).
- Conditions
- HIV Infections, HIV-1-infection, HIV-2 Infection
- Keywords
- HIV, HIV cure, HIV reservoir
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop a prospective cohort in the Netherlands of chronic HIV infected patients within-depth reservoir characterization for future cure interventions.
The HIV latent reservoir will be characterised in chronic HIV patients using novel techniques like FISH-flow
Measured: 5-10 years
To study the evolution of the HIV reservoir and immune host responses over time during antiretroviral therapy.
The HIV reservoir will be characterised over time to study the dynamics of the reservoir
Measured: 5-10 years
Secondary outcomes (3)
To explore established and putative new interventions aimed at curing HIV.
Blood and leucapheresis samples will be collected for testing of HIV cure drugs
Measured: 5-10 years
To explore differences in reservoir size, activity and host responses, and their relation with clinical characteristics, between patients with different dominant HIV subtypes and sexes.
Blood and leucapheresis samples will be collected for reservoir characterisation to compare reservoirs between patients
Measured: 5-10 years
To compare and validate new reservoir assays with current established assays.
Blood and leucapheresis samples will be collected to compare and validate new reservoir assays
Measured: 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start26 May 2021
- Primary completionJan 2027 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casper Rokx, Erasmus Medical Center
- Investigators
- Casper Rokx, MD PhD, Principal investigator, Erasmus Medical CenterTokameh Mahmoudi, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888754
- Sponsor's protocol ID
- NL72765.078.20
- Acronym
- CHRONO
- Status last verified
- Feb 2024
- First submitted
- 14 Apr 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No definitive decision on this yet. This will also depend on confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands: The CHRONO Project
- ClinicalTrials.gov ID
- NCT04888754
- Acronym / sponsor ID
- CHRONO / NL72765.078.20
- Conditions
- HIV Infections, HIV-1-infection, HIV-2 Infection
- Keywords
- HIV, HIV cure, HIV reservoir
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective non-interventional cohort study at Erasmus MC of adult chronic HIV infected patients of ≥18 years of age who initiate antiretroviral therapy in routine care.
Detailed description
HIV cannot be cured with the current treatment armamentarium. A reservoir of latently HIV infected long lived CD4+T-cells is present in patients with HIV that are not affected by antiretroviral therapy. The evolution of this reservoir after therapy initiation is ill understood, as are the potential strategies to eradicate this reservoir. This study aims to anticipate on future HIV cure strategies by building a cohort to study ex vivo the reservoirs of HIV patients, the obstacles to cure HIV, and new therapeutic compounds and strategies.
Main study parameters/endpoints:
- Change in viral reservoir size after antiretroviral treatment initiation.
- Evolution of phenotypical and functional aspects of the anti-HIV host immune responses.
- Ex vivo activity of established and novel HIV latency reversing agents.
- Variance in HIV reservoir and host immunity between HIV subtypes and clinical variables.
A project from the Erasmus MC HIV Eradication Group (EHEG).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are 18 years or older with a confirmed HIV infection without prior exposure to cART (treatment naïve). Prior use of pre-exposure prophylaxis is allowed.
Key inclusion criteria (3 listed)
- Age >18 years.
- Confirmed HIV-1 or HIV-2 infection
- Judged willing to initiate and adhere to cART by the HIV physician.
Key exclusion criteria (4 listed)
- Inability to place venous catheters to draw blood.
- Major comorbidities:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To develop a prospective cohort in the Netherlands of chronic HIV infected patients within-depth reservoir characterization for future cure interventions.
Time frame: 5-10 years
The HIV latent reservoir will be characterised in chronic HIV patients using novel techniques like FISH-flow
To study the evolution of the HIV reservoir and immune host responses over time during antiretroviral therapy.
Time frame: 5-10 years
The HIV reservoir will be characterised over time to study the dynamics of the reservoir
3 secondary outcomes
To explore established and putative new interventions aimed at curing HIV.
Time frame: 5-10 years
To explore differences in reservoir size, activity and host responses, and their relation with clinical characteristics, between patients with different dominant HIV subtypes and sexes.
Time frame: 5-10 years
To compare and validate new reservoir assays with current established assays.
Time frame: 5-10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Undecided. No definitive decision on this yet. This will also depend on confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Casper Rokx, MD PhD principal investigator
Erasmus Medical Center
Tokameh Mahmoudi, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HIV-1-infection, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop a prospective cohort in the Netherlands of chronic HIV infected patients within-depth reservoir characterization for future cure interventions. (time frame: 5-10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.